Preparedness for the inevitable: overcoming obstacles to a timely and effective R&D response. The WHO Blueprint Team

Transcription

1 Preparedness for the inevitable: overcoming obstacles to a timely and effective R&D response The WHO Blueprint Team

2 Context of the Blueprint WHO Executive Board 1 (January 2015) WHO Summit on Ebola R&D (May 2015) World Health Assembly (May 2015) 1 Special Session on Ebola, 25 January, 2015

3 World Health Assembly.welcomed the development of a Blueprint in consultation with Member States and relevant stakeholders for accelerating research and development in epidemics or other health emergency situations where there are no, or insufficient, preventive, and curative solutions, taking into account other relevant work-streams within WHO

4 Objectives Preempt development of public health emergencies: Implement roadmap for R&D preparedness, Enable prompt roll-out of emergency R&D plan during outbreaks of highly infectious pathogens

5 Key milestones September 2015: Submit summary to the UNSG High Level Panel on Global Response to Health Crises May 2016: Blueprint endorsed by WHA

6 Five workstreams 1. Mechanism to prioritize pathogens for research and product development 2. R&D preparedness: gap analysis and identification of research priorities for the priority diseases MERS Roadmap 3. Organization of stakeholders and strengthening of capacities 4. M&E of preparedness level and of interventions 5. Funding options for preparedness and emergency response

7 Blueprint activities and functions

8 Organization of blueprint secretariat Lead: Marie-Paule Kieny Coordinator: Bernadette Murgue Work-stream leaders: WS-1: Cathy Roth WS-2: David Wood MERS R&D Roadmap: Vasee Moorthy WS-3: Ana Maria Henao Restrepo WS-4: Claudia Nannei WS-5: Peter Beyer Working groups: WHO staff and external participants

9 Scientific Advisory Group Dr Abraham ASEFFA Armauer Hansen Research Institute Ethiopia Dr Manica BALASEGARAM Médecins Sans Frontières Switzerland Dr Jarbas BARBOSA (TBC) Agencia Nacional de Vigilancia Sanitaria Brazil Dr Maharaj Krishan BHAN Ministry of Sciences and Technology India Pr Lucille BLUMBERG National Institute for Communicable Diseases South Africa Dr Mimi DARKO Food and Drugs Authority Ghana Pr Jean François DELFRAISSY Agence Nationale de Recherche Sida et Hépatites France Pr Serge EHOLIE Université Félix Houphouet-Boigny Ivory Coast Dr Jeremy FARRAR Wellcome Trust UK Dr Zijian FENG Center for Diseases Control and Prevention China Dr Michel GRECO Parteurop Pharma France Dr Marion GRUBER Food and Drug Administration USA Pr Elizabeth HALLORAN University of Washington USA Dr Young-Mee JEE National Institute of Health Republic of Korea Pr Yoshihiro KAWAOKA (TBC) University of Wisconsin USA Pr Marion KOOPMANS Erasmus University of Rotterdam Netherlands Dr Line MATTHIESSEN European Commission EU Pr Vinh Kim NGUYEN Université de Montréal Canada Dr Robin ROBINSON Department of Health and Human Services USA Dr John-Arne ROTTINGEN Norwegian Institute of Public Health Norway Dr Chris WILSON Bill & Melinda Gates Foundation USA

10 Blueprint consultations 1. Biobanking: 6-7 August 2015; Freetown 2. Data sharing: 1-2 September; Geneva 3. Pre-clinical models: October; Washington DC 4. Clinical trial design: October; Welcome Trust 5. Funding models & governance: October; Oslo 6. Biobanking: November; Geneva

11 Blue print Work streams

12 1. Mechanism to prioritize pathogens for research and product development Determination of R&D priorities pathogens develop criteria and review process to assess o severe emerging epidemic-prone diseases with potential to cause a public health emergency Define a mechanism to trigger and initiate an urgent research response during a public health emergency o new pathogens which may emerge Criteria will consider risks and available tools

13 2. R&D preparedness: gap analysis and identification of research priorities Identify and facilitate the "background" research required for preparedness for future events must be performed in the inter-epidemic period Technical outputs will include, e.g.: Target product profiles, Reference standards and preparations, Regulatory specifications focus on basic research, proof-of-principle studies, preclinical and early phase clinical studies, behavioral research identify technologies with broad potential applications develop strategies for use of existing and innovative health technologies promote regulatory science to develop adapted regulatory pathways

14 Pathogen-specific case study of a fully developed R&D roadmap This will: Articulate strategic goals for preparedness efforts Development of point of care diagnostics Pre-positioning of candidate preventives and/or therapeutics for use in emergency Express agreed priority activities for initiation during 2016 in areas of research, product development, and key capacities to achieve above objectives Strengthened assays, and preclinical models Validation of platform technologies for vaccine Identify potential partners to implement the roadmap 14 Case study: MERS CoV?

15 3. Organization, coordination of stakeholders and strengthening of capacities Investigate stakeholder engagement-plan and governancestructure to promote collaboration with national and International actors: How to ensure national leadership and ownership? International coordination? Who should convene? Reach consensus on various frameworks for collaboration Data sharing, Biobanking, Standard MTAs, agreements for clinical trial consortia, agreements with manufacturer, ToRs for national research oversight committees, management of intellectual property, clinical trials protocols, etc. Prioritize research capacity strengthening investments to facilitate engagement of LMICs Identify networks and centres to engage in future work map current and potential resources and sites encourage further networking connections Develop guidance on good practices for community engagement

16 4. Assessment of preparedness and impact of interventions Develop procedures to evaluate and monitor: level of preparedness (enabling environment) impact of interventions on next emergency Identify key evaluation parameters e.g. inclusiveness, effectiveness, impact, sustainability.

17 5. Funding options for preparedness and emergency response Explore options for R&D preparedness funding e.g. Pooled resources in R&D fund(s), e.g. the "CEWG voluntary fund" managed by TDR Joint planning with individual implementation by different entities What financing for R&D during an emergency e.g. Earmarked contribution from WHO contingency funds, from new World Bank finance facility GLOPID model Financing of product R&D hubs (e.g. GSK proposal for vaccines) Options for better coordination of existing funds Innovative financing models